TAMPAXTAMPONSRADIANTRADIANTMIXEDUNSCNT28CT
Report
- Report Number
- 1219109-2024-00307
- Event Type
- Malfunction
- Date Received
- September 25, 2024
- Report Date
- November 20, 2024
- Manufacturer
- TAMBRANDS MANUFACTURING, INC
- Product Code
- HEB
- PMA / PMN Number
- K110669
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
NO FAILURE COULD BE IDENTIFIED AS A RESULT OF THE INVESTIGATION.
PRODUCT INVESTIGATION IS IN PROGRESS.
PRODUCT INVESTIGATION IS IN PROGRESS.
TAMPON FELL APART INSIDE OF ME [FOREIGN BODY IN REPRODUCTIVE TRACT], TAMPON FELL APART, BIG PIECES THAT BROKE OFF [DEVICE BREAKAGE], WHEN I WENT TO TAKE IT OUT IT FELL APART INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL] . CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT WHEN SHE TOOK OUT THE TAMPON IT FELL APART INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
TAMPON FELL APART INSIDE OF ME [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON FELL APART, BIG PIECES THAT BROKE OFF [DEVICE BREAKAGE]. WHEN I WENT TO TAKE IT OUT IT FELL APART INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT WHEN SHE TOOK OUT THE TAMPON IT FELL APART INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
TAMPON FELL APART INSIDE OF ME [FOREIGN BODY IN REPRODUCTIVE TRACT]. TAMPON FELL APART, BIG PIECES THAT BROKE OFF [DEVICE BREAKAGE]. WHEN I WENT TO TAKE IT OUT IT FELL APART INSIDE OF ME [COMPLICATION OF DEVICE REMOVAL]. CASE NARRATIVE: CONSUMER REPORTED VIA PHONE THAT WHEN SHE TOOK OUT THE TAMPON IT FELL APART INSIDE OF HER. NO SERIOUS INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2199138 | TAMPAXTAMPONSRADIANTRADIANTMIXEDUNSCNT28CT | TAMPON, MENSTRUAL, UNSCENTED - HEB | HEB | TAMBRANDS MANUFACTURING, INC | 3073243022101231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |